TEMPEDY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 15, 2016 Seiratherm GmbH Mike Johnson, M.D. Philosopher's River LLC PO Box 106 Willow Creek, MT 59760 Re: K152946 Trade/Device Name: tempedy 5000 system Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX, LGZ Dated: August 5, 2016 Received: August 16, 2016 Dear Dr. Mike Johnson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, M.A. Hillebrand for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K152946 ## Device Name Seiratherm GmbH tempedy 5000 ### Indications for Use (Describe) The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # Section 5 # 510(k) Summary This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 06-30-2016 [21 CFR 807.92(a)(1)]. #### Applicant Name and Address [21 CFR 807.92(a)(1)] A. Seiratherm GmbH Beethoven Street. 10 91074 Herzogenaurach Bavaria Tel: +49 89 80 91 31 420 Fax: +49 89 80 91 31 421 #### B. Contact Information Philosopher's River llc P O Box 106 Willow Creek, MT 59760 Tel: 406-209-3039 Fax: 406 2093039 Contact person: Mike Johnson M.D. mike@philosophersriver.com {4}------------------------------------------------ #### C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] Trade Name: tempedy 5000 system Device Common Name: Thermal regulating system Classification Name: System, Hypothermia, Intravenous, Cooling 21 CFR 870.5900 Product Code: NCX Device Classification: Class II #### D. Predicate Devices [21 CFR 807.92(a)(3)] The tempedy system uses similar technology and physical output characteristics as the following predicate devices: - K080899 Artic Blast Intravenous Fluid Chiller (similar infusion of cold iv ● fluid to cool patient) from Medivance Inc. NCX Thermal regulating system - K082217 Ranger Rapid Flow Blood/Fluid Warning System (similar infusion ● of warm iv fluid to warm the patient) from Arizant Healthcare Inc. LGZ Unclassified - K080908 RapidBlue System (similar patient temperature control of cooling ● or warming of the patient) from INNERCOOL Therapies Inc. NCX Thermal regulating system #### E. Device Description [21 CFR 807.92(a)(4)] The Seiratherm tempedy System is an adjunct to normalizing the body temperature of adults. It is intended to be used in situations when the patient is hypothermic and requires warming or when the patient is hyperthermic and requires cooling. - 1. It is an intravenous fluid cooling system The tempedy allows the operator to control temperature (4° to 42°) and flow rate of a crystalloid iv solution. This function has as its predicate, the Medivance Inc. Artic Blast Fluid Chiller. A salient difference is that the tempedy allows precise control of the flow rate and the predicate relies on gravity. - 2. It is an intravenous fluid warming system The tempedy when it warms the crystalloid iv solution, functions similarly to its predicate, the Arizant Healthcare Inc. Ranger Rapid Flow System. However, the tempedy precisely controls flow whereas the predicate uses pressure of 300 mmHg to cause flow without monitoring flow rate. {5}------------------------------------------------ - 3. It is a thermal regulating system with feedback of patient's temperature The tempedy may be used in conjunction with a patient temperature sensor. The flow rate for a preset temperature of iv fluid may be feedback controlled toward a target temperature setpoint. When used in this temperature feedback mode, the tempedy is similar to a third predicate, the INNERCOOL Therapies, Inc. RapidBlue System. A difference is that the RapidBlue System uses a closed loop circulation and heat exchanger to cool/warm the patient. Because of this catheter, the RapidBlue must have a central line access. The tempedy may be used with a peripheral or central catheter access. Both systems use a YSI 400 compatible temperature probe. The tempedy System does not deliver drugs. It is not a drug infusion device. The tempedy System does not deliver colloids (blood products, plasma, lipids, etc.) It is only for delivery of crystalloids (normal saline, Ringers, etc.). The tempedy System includes the following accessories: Power cord, Tubg Set, and Temperature Probe. A list of accessories is on Page 50 of the Instructions for Use Manual. Patient contacting parts: The sterile "Tubing Set T0" is a patient contacting part of the system. The Tubing Set TO is a single use part in the tempedy System. The GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YS1 400 compatible temperature probe is also a patient contacting part of the system. It is a manufacturer sterilized, single use part. F. Principle of Operation: The tempedy System has two insulated compartments ("thermal chambers") for storing iv crystalloid solutions at operator specified temperature. The 1 liter iv bags hand on a rack in each compartment. Each compartment has a Peltier device and a fan, which act as a heat pump to the ambient environment. This allows the usre to specify the temperature of each of the compartments individually. One compartment is designated "Cool" and other "Warm" by the operator. By independently controlling the flow rate of iv solution from each compartment and mixing the tow flows, a specified output temperature is obtained. This output temperature may be changed rapidly by changing the relative flow rates if the desired temperature is between the selected "Warm" and "Cool" compartments. #### G. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)] The predicate devices used to argue substantial equivalence are the K080899 Medivance, Inc. Arctic Blast Intravenous Fluid Chiller, K082217 Arizant Healthcare Inc. Ranger Rapid Flow blood/fluid warming system, and INNERCOOL therapies Inc. RapidBlue System. Below is a comparison table. {6}------------------------------------------------ | Characteris<br>tic | Seiratherm GmbH<br>tempedy | Medivance,<br>Inc. Arctic<br>Blast<br>Intravenous<br>Fluid Chiller | Arizant<br>Healthcare Inc.<br>Ranger Rapid<br>Flow<br>blood/fluid<br>warming<br>system.<br>Now owned by<br>3M. | INNERCOOL therapies<br>Inc. RapidBlue System | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicable<br>510(k)s | NA | K080899 | K082217 | K080908<br>K033623 | | Common/Us<br>ual Name<br>Classificatio<br>n Name | Thermal Regulating<br>System<br>Blood/Fluid<br>Warmer<br>System,<br>hypothermia,<br>intravenous cooling | Thermal<br>regulating<br>system<br>System,<br>hypothermia,<br>intravenous<br>cooling | Blood/Fluid<br>Warmer with<br>Pressure Infusor | Thermal regulating system<br>System, hypothermia,<br>intravenous cooling | | Panel | General and Plastic<br>Surgery | General and<br>Plastic Surgery | General Hospital | General and Plastic Surgery | | Product<br>Code<br>Regulation<br>Number | NCX / LGZ<br>21 CFR 870.5900 /<br>Unclassified | NCX<br>21 CFR<br>870.5900 | LGZ<br>Unclassified | NCX / LGZ<br>21 CFR 870.5900 | | Indications<br>for Use<br>Statement | The Seiratherm<br>GmbH tempedy is<br>intended to deliver<br>cooled sterile<br>solutions and<br>warmed sterile<br>solutions to adult<br>patients. | The Artic Blast<br>Intravenous<br>Fluid Chiller is<br>intended to cool<br>sterile solutions<br>during<br>intravenous<br>administration<br>where clinically<br>indicated for<br>reduction of<br>patient<br>temperature. | The Ranger Rapid<br>Flow Blood/Fluid<br>Warming System<br>is intended to<br>deliver warm<br>blood, blood<br>products, and<br>liquids to adult and<br>pediatric patients. | The RapidBlue System is a<br>thermal regulating system<br>intended to induce, maintain,<br>and reverse mild<br>hypothermia in neurosurgical<br>patients in surgery and in<br>recovery/intensive care, to<br>achieve and/or maintain<br>normothermia in cardiac<br>surgery patients in surgery<br>and in recovery/intensive<br>care, and for the use in fever<br>reduction, as an adjunct to<br>other antipyretic therapy, in<br>patients with cerebral<br>infarction and intracerebral<br>hemorrhage who required<br>access to the central venous<br>circulation and who are<br>intubated and sedated. | | Classificatio | Class II | Class II | Class II | Class II | | n | | | | | | Infusion<br>Pump | Flow rate control<br>1-250 ml/min | Gravity infusion | Pressure of 300<br>mmHg<br>flow rates up to<br>30,000 mL per<br>hour | Flow rate control of closed<br>loop system. | | Safety<br>Features | Air bubble<br>detection, pressure<br>& temperature<br>sensors | NA | Air bubble<br>detection<br>Fluid level<br>detection | Air trap, temperature sensors | | Cooling<br>Mechanism | Two chamber<br>heating and cooling<br>chambers with<br>controlled mixing | Heat exchanger<br>assembly and<br>adsorption<br>cooling module | NA | Refrigeration and hating<br>elements with heat<br>exchanger. | | Heating<br>Mechanism | Two chamber<br>heating and cooling<br>chambers with<br>controlled mixing | NA | Warming plates | Refrigeration and hating<br>elements with heat<br>exchanger. | | Temperature<br>Range | 4°C - 42°C | 4°C - 6°C | 42°C | 4°C - 42°C | | Feedback of<br>Patient<br>Temperature | Yes | No | No | Yes | | Patient<br>Temperature<br>Sensor | Off the shelf<br>temperature probes<br>such as YSI-400<br>esophageal, bladder<br>or rectal probes | NA | NA | Off the shelf temperature<br>probes such as YSI-400<br>esophageal probes or probe<br>integrated into the central<br>venous catheter. | | Operator<br>Controls and<br>Displays | Graphical User<br>Interface<br>(Touchscreen<br>Monitor) | NA | Display of<br>temperature and<br>warming unit<br>status. | Graphical User Interface<br>(Touchscreen Monitor) | | Alarms | Audible and visual<br>alarms. | None | Audible and visual<br>under and over<br>temperature.<br>Alarms activate at<br>25°C, 45.5°C, and<br>46°C | Audible and visual alarms. | | Closed-Loop<br>Circulation<br>vs. Infusion | Infusion | Infusion | Infusion | Closed-loop fluid circulation<br>with heat exchange at distal<br>end of endovascular catheter. | | Infusion<br>Fluid | Crystalloid Fluids | Crystalloid<br>Fluids | Crystalloid or<br>Blood Products<br>Fluids | No infusion | | Fluid<br>Contacting<br>Pathway | Disposable sterile<br>tubing set | Disposable<br>sterile tubing set | Disposable sterile<br>tubing set | Disposable sterile tubing set | | Sterilization<br>Method | 100% EO | 100% EO | 100% EO,<br>reference Isomedix<br>Soft Cycle | 100% EO | {7}------------------------------------------------ {8}------------------------------------------------ | Disposable<br>Packaging | Box and pouch.<br>Packaging validated. | Box and pouch. | Box and pouch.<br>Made of<br>polyethylene and<br>tyvek header.<br>Packaging<br>validated | Box and pouch. | |-----------------------------------------------------------------------|----------------------------------------|----------------|------------------------------------------------------------------------------------------|----------------| | Equivalence<br>determined<br>by<br>Performance<br>/ Clinical<br>Trial | Performance | Performance | Performance | Performance | #### H. Indications for Use [21 CFR 807.92(a)(5)] The Seiratherm tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients. #### I. Nonclinical Tests [21 CFR 807.92(b)(1)] | Test | Test Method | Results | | |-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--| | | Summary | | | | Infusion Essential Function and Safety<br>Testing<br>Third Party Testing to EN 60601-2-24:<br>2012-10 | Safety and infusion<br>accuracy tests<br>performed by Third<br>Party. Subsets of this<br>testing is described | Pass on all clauses. | | | Spillage testing | below. Acceptance<br>Criterion = "a.c."<br>Test per IEC 60529. | Pass | | | IEC 60529 - IPX2<br>Clause 201.11.6.3 and 5 | IPX2 | | | | Unintended bolus testing<br>Clause 201.12.4.4.104 | For Min/max occlusion<br>pressure, time to<br>occlusion alarm (a.c. <<br>2.5 s), measurement of<br>surplus bolus (a.c.<br><5ms) | Time to occlusion alarm <<br>2.5s. No measureable<br>unintended bolus. Pass. | | | Reverse delivery testing<br>Clause 201.12.4.4.105 | Visual inspection | No instance of reverse<br>flow. Pass. | | | Fitting of tubing, alarms<br>Clause 201.15.101 and 102 | Alarm at incorrect<br>positioning of tubing,<br>bubble detection,<br>traction to patient. (a.c.<br>100% function) | Pass | | | Use errors / alarms<br>Clause 201.15.103 | 2 actions required<br>before flow after alarm<br>or a start up | Pass | | | Infusion Accuracy - Bolus Accuracy<br>Clause 201.12.1.106 | Minimum and maximal boluses<br>were delivered and measured by<br>weight. | All boluses (n=25) were<br>delivered with acceptance<br>criterion of <6%. Pass | | | Infusion Accuracy - Flow Accuracy<br>Clause 201.12.1.107 | Start Up Diagrams and Trumpet<br>Diagrams<br>Flow Pump 1<br>Pump 2<br>3500<br>4000<br>4000<br>4000 | All Flow Rates within<br>acceptance criterion of<br><6%. Pass | | {9}------------------------------------------------ | | 7500 | 7500 ml/h | | |-------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------|--| | Temperature Sensing Accuracy<br>DIN EN ISO 80601-2-56 | Temperature<br>Management Mode | Tprobe=Tdisplay=Tservice connection (+/- 0.2°C).<br>Pass | | | 038_20160725_performance cooling | Cooling infusion in<br>Temperature<br>Management Mode | Appropriate<br>responses to<br>cooling. | | | 039_20160727_performance warming | Warming infusion in<br>Temperature<br>Management Mode | Appropriate<br>responses to<br>warming | | Performance tests: The EN 60601-2-24 guided bench testing of the tempedy. The ISO 80601-2-56 guided testing of the GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YSI 400 compatible temperature sensor. Safety tests: The tempedy was tested to the 60601-1 and 60601-1-2 consensus standards. Third party testing reports were submitted. | Test | Results | Conclusions | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | iso 10993-1 Biological<br>evaluation of medical<br>devices – Part 1:<br>Evaluation and testing | | | | Hemocompatibility<br>iso 10993-4 Hemolysis | Test material does not<br>release substances in<br>hemolytic conentrations<br>during 24 h contact of 4.5<br>cm2 surface area to 1 ml<br>of physiological fluid. | Tubing set does not cause<br>hemolysis. | | Cytotoxicity, L929-<br>Proliferation<br>iso 10993-5, -12 | Test material does not<br>release substances in<br>cytotoxic concentrations<br>during 24 h contact of 4.5<br>cm2 surface area to 1 ml<br>physiological fluid. | Tubing set is not cytotoxic. | | Chemical analysis,<br>characterization of organic<br>leachables / extractables<br>iso 10993-12, -18 | Extraction tests on the<br>test materials were<br>performed with organic<br>and aqueous solutions at<br>37°C. | The extractable substances are not<br>released in toxicologically relevant<br>concentrations during clinical<br>application. | Biocompatibility tests (Tubing Set T0): See table below: {10}------------------------------------------------ #### J. Conclusion [21 CFR 807.92(b)(3)] The Seiratherm GmbH tempedy 5000 was found to be substantially equivalent to the predicate devices, in terms of technology, function and intended use. The indications for use are similar to the previously cleared devices INNERCOOL Therapies Inc. RapidBlue System (K080908), Arizant Healthcare Inc. Ranger Rapid Flow (K082217), and Medivance, Inc. Arctic Blast (K080899). We believe that there are no new questions of safety or efficacy raised by the introduction of the tempedy 5000 System.